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A must-read for professionals navigating regulatory landscapes! Read the full case study https://lnkd.in/dcAqVXNZ #medicaldevices #regulatorycompliance #casestudy #eumdr #mdrregulation

📢 Attention Medical Device Manufacturers: Share Your Feedback on MDR/IVDR! The European Commission is seeking input from the medical device industry regarding the MDR/IVDR framework. This is an opportunity to share your experiences and challenges as one of the key stakeholders and contribute to the development of a better regulatory framework. 💡 Why is your feedback important? Your insights can help shape improvements to the framework, ensuring a more efficient and balanced system for all stakeholders. 👉 Take action now and make your voice heard: https://brnw.ch/21wPy8F #MDR #IVDR #Regulations #NotifiedBody #MedicalDevices #Feedback

The European Union Medical Device Regulation (EU MDR) categorizes medical devices into four classes based on their potential risk of harm to users: Class I, Class IIa, Class IIb, and Class III. Our recent article provides an overview of the EU MDR classification rules, examples of devices in each class, and regulatory requirements. You can read the full article to learn more about EU MDR medical device classification: https://lnkd.in/ddCjjHUZ #MedicalDevices #EUMDR #MDRCompliance

The clock is ticking for medical device manufacturers to meet EU MDR deadlines, and the certification process is slowing down. As more manufacturers submit their technical files late, notified bodies are overwhelmed—leading to longer approval timelines. My colleagues, medical device regulatory experts Hilde Viroux and Chris Illman explain how manufacturers can prioritise submissions to ensure timely approval and market access. #EUMDR #RegulatoryCompliance #MedTech

The clock is ticking for medical device manufacturers to meet EU MDR deadlines, and while this is not a new topic, the truth is that the certification process is slowing down. As more manufacturers submit their technical files late, notified bodies are overwhelmed—leading to longer approval timelines. My colleagues, medical device regulatory experts Hilde Viroux and Chris Illman explain how manufacturers can prioritise submissions to ensure timely approval and market access. #EUMDR #RegulatoryCompliance #MedTech

Our team delivered a strategy that supported this medtech client on their first step towards launching a borderline medical device in the EU market. Start reading: https://lnkd.in/e-CU6Rsu 💡 This case study covers how we helped the client overcome their challenges which led to the notified body signing an agreement to start the MDR certification procedure. #medtech #medicaldevices #MTF2024

Legacy medical devices approved under the old Medical Device Directive must transition to full compliance with the EU MDR by December 31, 2024. This crucial update impacts clinical evaluations, technical documentation, and post-market surveillance plans, demanding precision and adherence to new regulatory standards. At Marti Farm, we specialise in helping businesses navigate regulatory transitions seamlessly. Contact us at bd@martifarm.com or visit our website to ensure your devices stay compliant and market-ready. #MedicalDevices #MDRCompliance #RegulatoryAffairs #PostMarketSurveillance

🩺 Medical device manufacturers are facing the biggest EU regulatory shift in recent history. The MDR and IVDR are putting more pressure on MedTech companies with every device needing to be registered with and certified by the purpose-built European database of medical devices - EUDAMED. These new measures are excellent for improving the quality of the end product. Still, at the same time, they are threatening innovation, as organizations need to create increasingly complex documents faster. Find out how you can boost medical and in vitro device compliance with intelligent content in our new white paper. Read more here 👉 https://hubs.ly/Q02G0st60 #StructuredContent #ComponentContentManagementSystem #CCMS #StructuredContentAuthoring

Medical device manufacturers are facing a major challenge with the EU MDR transition. Delays in technical file submissions, combined with slow notified body accreditations, are creating a bottleneck that could extend approval timelines well beyond the deadline. Manufacturers who wait until the last minute may face certification delays of 18 months or more, impacting their market access and patient care. In this article, medical device regulatory experts Hilde Viroux and Chris Illman explain how manufacturers plan to stay ahead and avoid the end-of-transition rush. #EUMDR #MedicalDeviceManufacturers #MedTech https://lnkd.in/grwDwmU4

Medical device manufacturers are facing a major challenge with the EU MDR transition. Delays in technical file submissions, combined with slow notified body accreditations, are creating a bottleneck that could extend approval timelines well beyond the deadline. Manufacturers who wait until the last minute may face certification delays of 18 months or more, impacting their market access and patient care. In this article, medical device regulatory experts Hilde Viroux and Chris Illman explain how manufacturers plan to stay ahead and avoid the end-of-transition rush. #EUMDR #MedicalDeviceManufacturers #MedTech